DIAMONDBACK 360® and DIAMONDBACK 360 PRECISION Coronary Orbital Atherectomy System (OAS)
FDA premarket approval P130005/S037 · decided 2023-07-28
Approval details
- PMA number
- P130005
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIAMONDBACK 360® and DIAMONDBACK 360 PRECISION Coronary Orbital Atherectomy System (OAS)
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2023-06-13
- Decision date
- 2023-07-28
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a labeling change to include additional language for one of the precautions in the Instructions for Use regarding the availability of surgical backup.
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